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U.S. Food and Drug Administration – The U.S. Food and Drug Administration today granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and immunotherapy. HNSCC is an aggressive, life-threatening disease for which there is a high unmet need for effective therapies.
Rybrevant Faspro is not indicated as a treatment for patients with oropharyngeal squamous cell carcinoma that is associated with human papillomavirus (HPV).
Approval was based on trial results showing that more than double the percentage of patients responded to the drug compared to currently approved therapies. This is the first approval in 10 years of a drug for patients with recurrent or metastatic HNSCC who had received prior platinum-based chemotherapy.
“Today’s approval represents a meaningful step forward for patients with head and neck squamous cell carcinoma, a disease where treatment options have historically been limited and outcomes remain poor,” said Angelo De Claro, M.D., director of the FDA’s Oncology Center of Excellence. “This therapy offers patients and their physicians a new option with the potential to make a real difference in people’s lives.”
The Accelerated Approval Program allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on surrogate or intermediate endpoints. In this case, accelerated approval of Rybrevant Faspro was granted based on overall response rate and duration of response. Since it is not yet confirmed whether this will translate into a clinically meaningful benefit in long-term outcomes, the FDA has required confirmatory studies to verify and describe clinical benefit.
In an open-label, multicenter clinical trial involving 102 patients with recurrent or metastatic HNSCC, Rybrevant Faspro had an overall response rate of 42%, meaning these patients saw their tumor either decrease in size or disappear. Of those patients who had a response, 56% had a response lasting six months or longer. Currently approved therapies are associated with an overall response rate of around 20% or less and poor outcomes.
The prescribing information for use as a single agent includes warnings and precautions for hypersensitivity and administration-related reactions, interstitial lung disease (ILD)/pneumonitis, dermatologic adverse reactions, ocular toxicity, and harm to an unborn baby.
The FDA granted Rybrevant Faspro Breakthrough Therapy designation for this indication. The approval was granted to Janssen Biotech, Inc.
Information source: FDA
